Behavioral Economic Approaches to Improve Palliative Care for Critically Ill Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 3,500
- 试验地点
- 20
- 主要终点
- Composite Measure: Length of Stay and In-Hospital Mortality
研究概览
简要总结
This is a pragmatic, stepped-wedge, cluster randomized trial testing the real-world effectiveness of two different electronic health record (EHR) behavioral interventions in improving a number of patient- and family-centered processes and outcomes of care among seriously ill hospitalized patients. The investigators hypothesize that outcomes can be improved without raising costs by requiring intensive care unit clinicians to (i) document a prognostic estimate and (ii) provide a justification if they choose not to offer patients the option of comfort-oriented care. To test this hypothesis the investigators will conduct a 33-month trial at 17 intensive care units in 10 hospitals using the same Cerner EHR within Atrium Health System.
详细描述
The PONDER-ICU trial aims to generate large-scale, experimental evidence regarding the real-world effectiveness of two different electronic health record (EHR) behavioral interventions in improving a number of patient- and family-centered processes and outcomes of care among seriously ill hospitalized patients. The interventions are designed to increase intensive care unit (ICU) physicians' and advanced practitioners' (physician assistants and nurse practitioners) engagement of critically ill patients and caregivers in discussions about alternative treatment options, including care focused on comfort. To achieve this goal, the investigators will conduct a 33-month pragmatic, stepped-wedge cluster randomized clinical trial at 17 ICUs within 10 Atrium Health System hospitals. The investigators hypothesize that outcomes can be improved without raising costs by requiring ICU clinicians to (i) document a prognostic estimate (Intervention A) and (ii) provide a justification if they choose not to offer patients the option of comfort-oriented care (Intervention B). Approximately 4,750 adult patients (1) with chronic life-limiting illness and receiving continuous mechanical ventilation for ≥48 hours will be enrolled. Participating hospitals will be randomized into 5 clusters of 2 hospitals each. Each hospital will first contribute a minimum of 5 months of data collection during usual care in a control phase. Then, using the step-wedge design, all hospitals will implement the two EHR-based interventions. The order in which the interventions will be adopted and the timing of adoption at each hospital will both be determined by random assignment. After 12 months of utilizing Intervention A or Intervention B, each hospital will adopt and implement the second intervention in combination with the other. By the end of the trial, all hospitals will have utilized the combined interventions for at least 4 months. The primary outcome is a composite measure of hospital length of stay and mortality. Secondary outcomes include an array of clinical outcomes, as well as palliative care-related process measures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Health Services Research
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥18 years old; AND
- •Admitted to 1 of the 17 participating ICUs; AND
- •Receipt of continuous mechanical ventilation for ≥ 48 hours (without interruption); AND
- •≥ 1 life-limiting illness present on admission (ICD-9/10 code or discrete medical history data from EHR in prior 12 months):
- •Chronic obstructive pulmonary disease
- •Congestive heart failure
- •Dementia (all types)
- •End-stage renal disease
- •Hematologic malignancy
- •Metastatic malignancy
- •Motor neuron disease
- •Pulmonary fibrosis
- •Solid organ malignancy
排除标准
- •Patients younger than 18 years old are excluded.
结局指标
主要结局
Composite Measure: Length of Stay and In-Hospital Mortality
时间窗: Duration of hospital stay, an expected average of 16 days
The primary outcome is a composite measure of hospital length-of-stay and mortality that ranks deaths along the length-of-stay distribution
次要结局
- 30-day hospital readmission(30 days)
- 30-day mortality(30 days)
- Palliative withdrawal of mechanical ventilation(Duration of hospital stay, an expected average of 16 days)
- 180-day mortality(180 days)
- Change in code status(Duration of hospital stay, an expected average of 16 days)
- Initiation of additional forms of life-support(Duration of hospital stay, an expected average of 16 days)
- Time to palliative care consult(Duration of hospital stay, an expected average of 16 days)
- Receipt of cardiopulmonary resuscitation (CPR)(Duration of hospital stay, an expected average of 16 days)
- ICU mortality(Duration of hospital stay, an expected average of 16 days)
- ICU length of stay(Duration of hospital stay, an expected average of 16 days)
- Duration of mechanical ventilation(Duration of hospital stay, an expected average of 16 days)
- Hospital discharge disposition(Duration of hospital stay, an expected average of 16 days)
- 90-day mortality(90 days)
- Palliative care consult(Duration of hospital stay, an expected average of 16 days)
- ICU readmission(Duration of hospital stay, an expected average of 16 days)
- Time to withdrawal of life-support(Duration of hospital stay, an expected average of 16 days)
- Quality of Dying & Death (1-item)(48-72 hours following an in-hospital death)
- 90-day hospital readmission(30 days)
- 180-day hospital readmission(30 days)
- Hospital free days(180 days)